FDA Orders Seizure of Adulterated Supplements

Norcross, GA—U.S. Marshals have seized more than $2 million worth of dietary supplements that contain an unapproved food additive from a supplement manufacturer.

The U.S. Food and Drug Administration (FDA) found products manufactured by Hi-Tech Pharmaceuticals, Inc., based here, that contained 1, 3-Dimethylamine HCI (DMAA) or its chemical equivalent. DMAA is an unapproved food additive, often marketed as a “natural” stimulant, which FDA has deemed unsafe due to the health problems it may cause, such as elevated blood pressure, heart attack, shortness of breath and tightening of the chest. Reports of death or psychiatric disorders have been associated with supplements containing DMAA, the effects of which may be elevated when combined with caffeine.

The inspection of Hi-Tech Pharmaceuticals, Inc., which began in October, uncovered 11 products whose labels indicated they contained DMAA. The adulterated supplements included Black Widow, Lipodrene, FASTIN, Stimerex-ES and ECA XTREME, all of which are marketed for weight loss and energy enhancement. In addition, FDA found bulk DMAA raw ingredients at the facility. On Nov. 12, U.S. Marshals seized the adulterated supplement material from the Norcross facility, which equated to more than 1,500 cases of finished goods and more than 1,200 pounds of raw material goods.

FDA sent out warning letters in 2012 to companies whose products contained the illegal additive instructing them to take the products off the market or reformulate them to exclude the unsafe substance.

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